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- Tasks: Engage with stakeholders to gather requirements and improve clinical processes.
- Company: Join a leading firm transforming clinical operations through technology and innovation.
- Benefits: Enjoy flexible work options, professional development opportunities, and a collaborative culture.
- Why this job: Make a real impact in healthcare while working with cutting-edge technology and diverse teams.
- Qualifications: In-depth knowledge of clinical trials and strong analytical skills are essential.
- Other info: Experience with global Pharma clients and Agile methodologies is preferred.
The predicted salary is between 36000 - 60000 £ per year.
Key Responsibilities:
- Requirement Gathering & Analysis
- Engage with Clinical Operations and cross-functional stakeholders to elicit and document business needs and pain points.
- Translate business requirements into clear, actionable Functional Specification Documents (FSDs).
- Develop Requirements Traceability Matrices (RTMs) to ensure alignment and accountability throughout the project lifecycle.
- Process Improvement & Thought Leadership
- Analyze existing clinical processes and workflows; identify areas for optimization.
- Recommend and design process improvements leveraging industry best practices and regulatory standards (e.g., ICH-GCP, CDISC, eTMF, CTMS).
- Provide thought leadership on innovative use of technology in Clinical Operations (AI/ML, automation, data analytics, etc.).
- Collaboration & Communication
- Work proactively and collaboratively with client stakeholders, technology teams, and Sonata\’s extended delivery team to drive alignment and delivery.
- Serve as the SME (Subject Matter Expert) liaison between Clinical Operations and technical implementation teams.
- Technology Enablement
- Provide business input and validation for configuration, integration, and deployment of clinical systems such as CTMS, EDC, eTMF, RTSM, and Safety systems.
- Ensure that implemented solutions meet both business and regulatory requirements.
- Participate in solution design reviews, testing (UAT), and change management initiatives.
- Project Delivery Support
- Support end-to-end implementation efforts including planning, execution, monitoring, and post-go-live support.
- Help define KPIs and success criteria for clinical operations initiatives and technology deployments.
Key Skills & Experience:
- Domain Expertise:
- In-depth knowledge of Clinical Trials and Clinical Operations processes.
- Familiarity with regulatory standards and industry frameworks (ICH-GCP, 21 CFR Part 11, DIA, etc.).
- Technology Understanding:
- Strong functional knowledge of clinical systems (CTMS, EDC, eTMF, RTSM, Safety/Pharmacovigilance platforms).
- Awareness of integration points, data flows, and interoperability across clinical platforms.
- Business Analysis Skills:
- Proven experience in creating high-quality functional specifications, process flows, and traceability matrices.
- Excellent analytical and problem-solving skills; ability to think strategically and execute tactically.
- Communication & Collaboration:
- Strong interpersonal skills with the ability to work across business and technical teams.
- Proactive, self-driven, and able to manage multiple stakeholders and priorities effectively.
- Tools:
- Proficiency in tools such as Jira, Confluence, Visio, MS Office, and requirement management platforms.
Preferred Qualifications:
- Experience working with global Pharma/Biotech clients.
- Exposure to Agile/Scrum and/or Waterfall project methodologies.
- Certification in Business Analysis (e.g., CBAP, PMI-PBA) or Clinical Research (e.g., ACRP, SOCRA) is a plus.
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Business Consultant - Clinical Operations & Technology employer: E-Solutions
Contact Detail:
E-Solutions Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Business Consultant - Clinical Operations & Technology
✨Tip Number 1
Familiarise yourself with the latest trends in clinical operations and technology. Understanding how AI, machine learning, and data analytics are being integrated into clinical trials can give you an edge during discussions with potential employers.
✨Tip Number 2
Network with professionals in the clinical operations field. Attend industry conferences or webinars to connect with key players and learn about their challenges and needs, which can help you tailor your approach when applying for the role.
✨Tip Number 3
Brush up on your knowledge of regulatory standards like ICH-GCP and 21 CFR Part 11. Being able to discuss these frameworks confidently will demonstrate your expertise and commitment to compliance in clinical operations.
✨Tip Number 4
Prepare to showcase your experience with tools like Jira and Confluence. Being able to discuss specific projects where you've used these tools effectively can highlight your practical skills and readiness for the role.
We think you need these skills to ace Business Consultant - Clinical Operations & Technology
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in Clinical Operations and Business Analysis. Use keywords from the job description, such as 'Functional Specification Documents' and 'Requirements Traceability Matrices', to demonstrate your fit for the role.
Craft a Compelling Cover Letter: In your cover letter, explain why you are passionate about Clinical Operations and how your skills align with the responsibilities outlined in the job description. Mention specific examples of process improvements you've implemented or technology solutions you've worked with.
Showcase Your Technical Skills: Emphasise your proficiency in tools like Jira, Confluence, and MS Office. If you have experience with clinical systems such as CTMS or EDC, make sure to highlight this as it is crucial for the role.
Demonstrate Communication Skills: Since strong interpersonal skills are essential, consider including examples of successful collaboration with cross-functional teams. Highlight any experience where you acted as a liaison between technical and non-technical stakeholders.
How to prepare for a job interview at E-Solutions
✨Understand the Clinical Operations Landscape
Familiarise yourself with the key processes and regulatory standards in clinical trials, such as ICH-GCP and CDISC. This knowledge will help you demonstrate your domain expertise and show that you can effectively engage with stakeholders.
✨Prepare Functional Specification Examples
Be ready to discuss your experience in creating Functional Specification Documents (FSDs) and Requirements Traceability Matrices (RTMs). Having concrete examples will illustrate your analytical skills and ability to translate business needs into actionable documents.
✨Showcase Your Technology Savvy
Highlight your understanding of clinical systems like CTMS and EDC, and be prepared to discuss how you've leveraged technology for process improvements. This will demonstrate your capability in technology enablement and innovation in clinical operations.
✨Emphasise Collaboration Skills
Prepare to share examples of how you've worked collaboratively with cross-functional teams. Strong interpersonal skills are crucial for this role, so showcasing your ability to manage multiple stakeholders and priorities will set you apart.
